NCT03843281

Brief Summary

The purpose of this study is to test the additional effect of paracetamol in combination with morphine for analgesia, respectively to test/confirm an opioid sparing effect due to the additional use of Paracetamol, as well as the reduction of adverse drug reactions of morphine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

February 14, 2019

Last Update Submit

October 15, 2020

Conditions

Analgesia

Keywords

ParacetamolMorphine

Outcome Measures

Primary Outcomes (1)

  • Assessment of the total dose of morphine till pain < 4 on the NRS (0-10) after the first infusion of paracetamol or placebo.

    up to 4 hours

Secondary Outcomes (3)

  • Assessment of time interval of pain < 4 on the NRS (after been achieved)

    up to 4 hours

  • Total dose of morphine within the first 4 hours after the first infusion of paracetamol or Placebo.

    up to 4 hours

  • Prevalence of morphine adverse reactions within the first 4 hours after infusion of paracetamol or placebo

    up to 4 hours, respectively in case of serious adverse events up to recovery time of the patient

Other Outcomes (1)

  • Maximal Dose of Morphine based on adverse events

    up to 4 hours

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol 1 g (100 mL) IV + Morphine 0.1 mg/kg IV (repeatable in Doses of 0.05 mg/kg), 100 patients over 4 hours

Drug: ParacetamolDrug: Morphine

Placebo

PLACEBO COMPARATOR

Placebo (NaCl 0.9% 100 mL IV) + Morphine 0.1 mg/kg IV (repeatable in Doses of 0.05 mg/kg), 100 patients over 4 hours

Drug: PlaceboDrug: Morphine

Interventions

ParacetamolDRUG

s. above

Also known as: Paracetamol Sintetica
Paracetamol
PlaceboDRUG

s. above

Also known as: NaCl 0.9%
Placebo
MorphineDRUG

s. above

Also known as: Morphine Sintetica
ParacetamolPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with pain with Pain-score is more or equal than four in a numeric rating scale from zero to ten (i.e. indication for a treatment with morphine)
  • Age over 18
  • Signed informed consent. In case, patient is not able to sign the informed consent due to pain, at least verbal consent has to be provided. After pain relief, written informed consent with data and time has to be obtained

You may not qualify if:

  • Analgesia in the past last 6 hours prior to visit at the emergency department
  • Current Analgesia with long-acting/extended-release drugs
  • Current Analgesia with opioids
  • Chronic pain syndrome
  • Contraindication for either paracetamol or morphine
  • Patient's refusal of paracetamol or morphine treatment
  • Pregnancy or Breastfeeding
  • GCS \< 13
  • SpO2 \< 90% with a maximum of 4 L/Min O2
  • Systolic Blood Pressure \< 90 mmHg
  • "Fast Track"/Notfallpraxis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Interventions

AcetaminophenSodium ChlorideMorphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

May 2, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)